On April 19, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company has entered into an agreement with MSD to initiate a Phase II combination trial of olinvacimab, an anti-VEGFR2 antibody, and KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in metastatic Triple-Negative Breast Cancer(mTNBC) (Press release, PharmAbcine, APR 19, 2021, View Source [SID1234578205]).

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The phase II clinical trial, an open-label, multicenter trial, will enroll immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level to evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after administering 16mg/kg of olinvacimab and 200mg of pembrolizumab.

The companies have entered this collaboration based on the promising clinical data obtained from the phase Ib olinvacimab and pembrolizumab study in mTNBC which is currently ongoing in Australia. According to the interim result as of September 2020, the combo therapy showed a manageable safety profile with 50% ORR (Overall Response Rate) and 67% DCR (Disease Control Rate) in patients who received olinvacimab plus pembrolizumab at the recommended phase 2 dose (RP2D) (N=6pts). In addition, 1 patient in PR (Partial Response) showed CR (Complete Response) in the target lesion and another PR patient showed CR in a non-target lesion.

Under the terms of the agreement, PharmAbcine will sponsor a phase II clinical trial that will take place in both Australia and South Korea, and MSD will supply KEYTRUDA.

"Helping cancer patients is core to our mission. Based on the safety profile and early clinical efficacy observed in the phase Ib trial, we feel we have a responsibility to explore olinvacimab in combination with pembrolizumab in mTNBC patients further in phase II," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We will try our best so the multinational clinical study can begin in the first half of 2021."

About Metastatic Triple Negative Breast Cancer (TNBC)
mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen receptor, progesterone receptors and human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is still very difficult to treat, and there are very few FDA approved treatment options for these patients.

About Olinvacimab

PharmAbcine’s leading pipeline, olinvacimab, an anti-VEGFR2 neutralizing fully human IgG, is currently in a phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the combination of olinvacimab and pembrolizumab trial in mTNBC, another olinvacimab plus pembrolizumab Phase Ib trial for rGBM is ongoing in Australia.

On April 19, 2021 ViewRay, Inc. (Nasdaq: VRAY) reported details relating to the release of its first quarter 2021 financial results (Press release, ViewRay, APR 19, 2021, View Source [SID1234578204]).

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ViewRay will hold a conference call to discuss results on Thursday, May 6, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (888) 771-4371 for domestic callers and (847) 585-4405 for international callers. The confirmation number is 50150605. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until May 13, 2021. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8484107.

On April 19, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2021 first quarter financial results on Tuesday, May 4, 2021 after the close of the financial markets (Press release, Jazz Pharmaceuticals, APR 19, 2021, View Source [SID1234578203]). Company management will host a live audio webcast at 4:30 p.m. ET/9:30 p.m. IST to discuss first quarter 2021 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. A replay of the webcast will be archived on the website for at least one week.

On April 19, 2021 ImmVira reported the preclinical study results of MVR-T3011 via intravenous administration through publication in a virtual poster at the AACR (Free AACR Whitepaper) annual meeting (Press release, Immvira, APR 19, 2021, View Source [SID1234578202]). MVR-T3011 is a replication competent and genetically modified oncolytic herpes simplex virus-1 expressing human interleukin-12 and anti-PD-1 antibody. ImmVira owns the global right for development and commercialization of MVR-T3011 via intravenous administration.

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Oncolytic virus(OV) has been proven to inhibit tumor growth in a number of superficial tumors through intratumoral injection. From clinical studies, intratumoral injection of OV has been proved to provide effective treatment against tumor via its abscopal effect, transitions from immunologically cold to hot tumor and combination with other cancer therapies. However, to advanced tumors, especially the lesions of multiple metastasis are ideally treated via a systemic route. At present, common types of viruses that have been studied clinically for intravenous administration are Vaccinia virus, Coxsackie virus and Reovirus etc. However, for various reasons, most virus types used in developing oncolytic viruses including HSV-1 and adenoviruses, have not been fully studied for intravenous administration preclinically and clinically.

In the preclinical study conducted by ImmVira, intravenous administration of MVR-T3011 demonstrated enrichment of viral DNA in tumor tissue. MVR-T3855, the surrogate of MVR-T3011 for mouse, was shown to significantly extend the survival time of several mouse with orthotopic tumors including primary and metastatic lung cancer and primary liver cancer, and repeated dose via intravenous administration has clearly enhanced antitumor effect. Furthermore, intravenous administration or intra-cavity of MVR-T3855 significantly delayed or prevented the formation of malignant ascites in mouse liver model. In terms of safety, the three-month pre-clinical study showed that the intravenous administration of MVR-T3011 and MVR-T3855 did not cause significant adverse reactions and had clinical significance. After administration, no histopathological change was found in non-target organs.

ImmVira submitted an IND application for MVR-T3011 intravenous administration to the U.S. FDA in January 2021 and expects to recruit patients in five leading U.S. research cancer centers within the next few weeks.

On April 19, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data demonstrating the clinical capability of the Percepta Genomic Atlas for informing lung cancer treatment decisions, as well as the technical feasibility of enabling the company’s Envisia Genomic Classifier on the nCounter Analysis System, will be presented at the American Thoracic Society (ATS) 2021 International Conference (Press release, Veracyte, APR 19, 2021, View Source [SID1234578201]). Multiple posters reinforcing the Envisia classifier’s diagnostic performance will also be presented at the meeting, which will be held virtually May 14-19, 2021.

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"We’re also very excited about the new data demonstrating that we can successfully enable the Envisia classifier on the nCounter system, maintaining the test’s clinical performance while enabling access for patients globally through local labs."

"The data being presented at ATS suggest that the Percepta Genomic Atlas can provide information that will accelerate appropriate treatment for patients following a lung cancer diagnosis and, importantly, that the test provides this information regardless of disease stage," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We’re also very excited about the new data demonstrating that we can successfully enable the Envisia classifier on the nCounter system, maintaining the test’s clinical performance while enabling access for patients globally through local labs."

The Percepta Genomic Atlas provides comprehensive genomic profiling information on cancerous lung nodules, utilizing small samples from the same biopsy used for diagnosis. Data to be shared at ATS show that the in-development test accurately detects known gene variants in lung cancer using bronchoscopy samples, potentially enabling earlier and more appropriate treatment with currently available and in-development targeted therapies.

The Envisia Genomic Classifier is a genomic test that detects a genomic pattern of usual interstitial pneumonia (UIP) to improve interstitial lung disease (ILD) diagnostic and prognostic confidence. The classifier is performed in Veracyte’s U.S.-based CLIA laboratory. In December 2019, Veracyte acquired the exclusive global diagnostics rights to the nCounter Analysis System, a CE-marked and FDA-cleared decentralized molecular testing platform. The company plans to make the Envisia classifier available on the nCounter platform in international markets by the end of this year.

Following are details of the Percepta Genomic Atlas and Envisia classifier posters accepted for presentation at ATS. These posters will be available to meeting registrants on demand beginning May 14 through July 2, 2021:

Title:

Identification of Driver Mutations in Transbronchial Needle Aspirates of Suspicious Lung Nodules Concurrent with Diagnostic Bronchoscopy, Abstract #A4825

First Author:

Joshua Babiarz, Ph.D., Veracyte

Title:

Envisia Genomic Classifier Demonstrates Consistent Performance Across Gender, Age Group, and Smoking Status. Abstract #A1839

First Author:

Luca Richeldi, M.D., Ph.D., Università Cattolica del Sacro Cuore, Rome, Italy

Title:

Envisia Genomic Classifier Helps Improve Multidisciplinary Diagnoses of Complex Interstitial Lung Diseases, Abstract #A1877

First Author:

Lisa H. Lancaster, M.D., Vanderbilt University Medical Center

Title:

Cryobiopsy and Genomic Classifier (Envisia) in the Diagnosis of Usual Interstitial Pneumonia, Abstract #A4236

First Author:

R. Ronaghi, M.D., University of California, Los Angeles

Title:

Role of the Envisia Genomic Classifier in Establishing a Diagnosis of Idiopathic Pulmonary Fibrosis, Abstract #1837

First Author:

M. Abdalla, M.D., Pulmonary and Critical Care Medicine, Medical College of Wisconsin

Title:

Bridging the Envisia Genomic Classifier to the nCounter Platform: A Proof-of-Concept Study, Abstract #A4352

First Author:

Huimin Jiang, Ph.D., Veracyte